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NCE — Injector, Capsular Tension Ring Class I

FDA Device Classification

FDA product code NCE covers "Injector, Capsular Tension Ring", a Class I medical device regulated under 21 CFR 886.4300. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NCE
Device Class
Class I
Regulation Number
886.4300
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042478duckworth and kentCAPSULE TENSION RING INSERTER, MODEL 7-810December 28, 2004
K011498ophtec usaEASY CONTROL MICRO INSERTER, MODEL ON385July 9, 2001
K001125geuderGEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RINGOctober 4, 2000

FDA data resources